The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs

The Effect of Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs in Intensive Care Patients: A Randomized Controlled Study

This study was planned to investigate the effects of eye patch and headphones on sleep quality, anxiety, fear and vital signs in coronary intensive care unit patients.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Syndrome
• Intervention / Treatment: Other: Eye patch and headphones

Detailed Description

In intensive care units, it can be much easier to change the environment perception of patients with simple tools such as headphones and sleep bands, rather than changing the environment of the patients. The use of sleep bands and headphones, which are non-pharmacological methods, can reduce sleep deprivation by changing the environmental perception of the patients.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34340
    • Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being 18 years or older,
• New York Heart Association (NYHA) functional class II and III,
• Not having received any general anaesthesia for the previous 24 hours,
• Not having received any sedative medications or opioids for the past 24 hours,
• Not having a verbal communication disability (hearing and speaking),
• Absence of pain,
• Not having a previously diagnosed sleep disorder,
• Not having psychiatric problems,
• Not having a cognitive problem,
• Being healthy enough to put on and take off earplugs independently, in addition to wearing an eye mask and removing it when necessary, and continuing to be hospitalized for at least three days.

Exclusion Criteria:

• Diagnosed with delirium (Intensive care delirium screening checklist >=5),
• Unconscious (Glasgow coma scale<13),
• Presence of additional chronic diseases,
• Having consumed coffee, alcohol and hypnotic drugs at least 12 hours before the study,
• Patients whose condition suddenly worsened,
• Those who cannot use earplugs and eye masks effectively at night,
• Those who voluntarily withdrew from the study and were transferred from the intensive care unit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Eye patch and headphones	Other: Eye patch and headphones; Patients in the experimental group will be asked to use an eye mask and earplugs from 22:30 to 6:30 in the morning on the 1st, 2nd and 3rd nights.
NO_INTERVENTION: Control group; Routine maintenance will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (Fear)	Patients are asked to show the severity of their fear on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	the first day after receiving randomisation
Visual Analog Scale (Anxiety)	Patients are asked to show the severity of their anxiety on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	the first day after receiving randomisation
Vital Signs Follow-up Form	This form was created by the researcher in order to record the systolic-diastolic blood pressure, and heart rate (pulse), values of the patient who was applied an eye patch or earphone at night.	the first day after receiving randomisation
The Richards-Campbell Sleep Questionnaire	This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.	the first day after receiving randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (Fear)	Patients are asked to show the severity of their fear on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	4. days
Visual Analog Scale (Anxiety)	Patients are asked to show the severity of their anxiety on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	4. days
Vital Signs Follow-up Form	This form was created by the researcher in order to record the systolic-diastolic blood pressure, and heart rate (pulse), values of the patient who was applied an eye patch or earphone at night.	4. days
The Richards-Campbell Sleep Questionnaire	This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.	4. days

Collaborators and Investigators

• Sponsor: Istanbul Sabahattin Zaim University
• Investigators: Study Director: Zülfünaz Özer, Istanbul Sabahattin Zaim University

Publications and helpful links

General Publications

• Kasapoglu ES, Enc N. Role of multicomponent non-pharmacological nursing interventions on delirium prevention: A randomized controlled study. Geriatr Nurs. 2022 Mar-Apr;44:207-214. doi: 10.1016/j.gerinurse.2022.02.015. Epub 2022 Feb 26.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2022
• Primary Completion (ACTUAL): November 15, 2022
• Study Completion (ACTUAL): November 15, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (ACTUAL): July 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Intensive Care Unit; Headphones; Sleep bands
• Other Study ID Numbers: 8991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No